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Clinical Trials (PDQ®)

Phase II Trial of Induction with L-ASP/CTX/DNM/PRED/VCR Followed by Intensive Consolidation in Adult Patients with Previously Untreated Acute Lymphocytic Leukemia

Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IITreatmentClosed15 and overNCICLB-8811
CALGB-8811

Objectives

I.  Determine, in a group-wide Phase II study, the feasibility and toxicity of 
an intensive chemotherapy program consisting of induction with 
L-asparaginase/cyclophosphamide/daunomycin/prednisone/vincristine 
(L-ASP/CTX/DNM/PRED/VCR) and intensification with cytosine 
arabinoside/L-ASP/CTX/6-mercaptopurine/VCR in previously untreated patients 
with acute lymphocytic leukemia.
II.  Determine the response rate to this induction regimen.
III.  Investigate the disease-free survival of complete responders who receive 
intensification and maintenance on protocol.
IV.  Investigate further the prognostic significance of immunophenotype, 
cytogenetics, and molecular analysis as well as such patient characteristics 
on entry as age, WBC and platelet counts, mediastinal mass, organomegaly, and 
lymphadenopathy.
V.  Investigate the prognostic significance of the day 7 bone marrow 
examination.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients aged 15 years and older with 
an unequivocal diagnosis of adult lymphoblastic leukemia (ALL) based on FAB 
classification (L1-L3), provided they have received no prior treatment other 
than emergency leukapheresis.  Cytochemical and immunologic studies performed 
at the treating institution must be consistent with the diagnosis.  All 
patients must simultaneously be entered on CLB-8364 (immunology); patients 
whose marrow is not aspirable on 2 attempts and whose blood does not contain 
ALL cells remain eligible for this study.  Additionally, concurrent 
registration on CLB-8461 (cytogenetics), CLB-8762 (molecular subtypes in 
Ph1-positive ALL), and CLB-8763 (Ig and TCR gene rearrangements in ALL) is 
strongly encouraged.  Management throughout the entire duration of protocol 
treatment must be carried out at a medical facility having ready access to 
blood product support and adequately staffed to care for the severely 
neutropenic patient with multiple therapy-induced toxicities.  Adequate 
hepatic and renal function must be documented by the following laboratory 
parameters, unless abnormalities are directly attributable to leukemia:  total 
bilirubin less than 1.5 times normal, alkaline phosphatase and SGOT/SGPT each 
less than twice normal, and serum creatinine less than 1.5 times normal 
(biopsies of liver or kidney are not required to document leukemic 
involvement).  There may be no previous or concomitant other malignancy except 
for curatively treated carcinoma in situ of the cervix or basal cell carcinoma 
of the skin.  Patients must be free from other serious medical illness that 
would limit survival to less than 2 years and any psychiatric condition that 
would prevent informed consent.  Specifically, there must be no uncontrolled 
or severe cardiovascular disease, including myocardial infarction within 6 
months and CHF; any viral, bacterial, or fungal infection and active duodenal 
ulcer must be controlled prior to entry.

Expected Enrollment

Approximately 112 patients will be entered over 18 months.

Outline

Nonrandomized study.  Patients who have testicular leukemia on admission and 
those who develop testicular involvement subsequently are treated according to 
Regimen A.  Patients who have CNS leukemia on entry or develop CNS disease 
subsequently are treated according to Regimen B.
Induction:  5-Drug Combination Chemotherapy.  Cyclophosphamide, CTX, 
NSC-26271; Daunorubicin, Daunomycin, DNM, NSC-82151; Vincristine, VCR, 
NSC-67574; Prednisone, PRED, NSC-10023; L-Asparaginase, L-ASP, NSC-109229.
Intensification:  5-Drug Combination Systemic Chemotherapy plus 2-Drug 
Combination Intrathecal Chemotherapy.  CTX; Cytarabine, Cytosine arabinoside, 
ARA-C, NSC-63878; 6-Mercaptopurine, 6-MP, NSC-755; VCR; L-ASP; plus 
Intrathecal Methotrexate, IT MTX, NSC-740; Intrathecal Hydrocortisone, IT HC, 
NSC-10483.
CNS Prophylaxis/Interim Maintenance:  2-Drug Combination Systemic Chemotherapy 
plus Single-agent Intrathecal Chemotherapy plus Radiotherapy.  MTX; 6-MP; plus 
IT MTX; plus whole-brain irradiation using Co60 equipment or linear 
accelerators with beam energies of 4-6 MeV.
Late Intensification:  6-Drug Combination Chemotherapy.  Doxorubicin, 
Adriamycin, ADR, NSC-123127; VCR; Dexamethasone, DM, NSC-34521; CTX; ARA-C; 
6-Thioguanine, TG, NSC-752.
Maintenance:  4-Drug Combination Chemotherapy.  6-MP; MTX; VCR; PRED.
Regimen A:  Radiotherapy.  Bilateral testicular irradiation using Co60 
equipment or linear accelerators with beam energies of 4-6 MeV.
Regimen B:  Single-agent Intrathecal Chemotherapy plus Radiotherapy.  IT MTX; 
plus whole-brain irradiation using Co60 equipment or linear accelerators with 
beam energies of 4-6 MeV.

Published Results

Larson RA, Dodge RK, Burns CP, et al.: A five-drug remission induction regimen with intensive consolidation for adults with acute lymphoblastic leukemia: cancer and leukemia group B study 8811. Blood 85 (8): 2025-37, 1995.[PUBMED Abstract]

Larson RA, Burns CP, Dodge RK, et al.: A 5-drug induction regimen with intensive consolidation for adult ALL. [Abstract] Proceedings of the American Society of Clinical Oncology 11: 263, 1992.

Related Publications

Wetzler M, Dodge RK, Mrózek K, et al.: Prospective karyotype analysis in adult acute lymphoblastic leukemia: the cancer and leukemia Group B experience. Blood 93 (11): 3983-93, 1999.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Cancer and Leukemia Group B

Richard Larson, MD, Protocol chair
Ph: 773-702-6783; 888-824-0200

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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